Diltiazem Hydrochloride
- Product NDC
- 51655-020
- 11-digit product format
- 516550020
- Labeler code
- 51655
- Product ID
- 51655-020_4aa22714-1786-0a81-e063-6394a90a090d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diltiazem Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA074185
- Marketing category
- ANDA
- Marketing start
- 2022-08-11
- Substance
- DILTIAZEM HYDROCHLORIDE
- Active strength
- 60 mg/1
- Pharmacologic classes
- Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A4 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diltiazem Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DILTIAZEM HYDROCHLORIDE | 60 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | OLH94387TE |
| Rxcui | 831103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-020-52 | Diltiazem Hydrochloride | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-020 | DILTIAZEM HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC] | 1 | Current NDC, 1 package rows | 20230207_f29febd6-5a27-eb83-e053-2a95a90a5b7d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 51655-020-52 | 51655002052 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-020-52) | 2022-08-11 | No | No | Current |